Formycon AG: Licensing Out of the First Biosimilar Development Project Already Enables Extension of the Product Pipeline as of 2014
- The long-term orientation of Formycon AG as a global biosimilar developer has been successfully achieved. The company ended the year 2013 with the out-licensing of the first development project.
- With Carsten Brockmeyer, Gerhard Schaefer and Simon Sturge, Formycon has appointed experienced pharma managers to the board of directors and the advisory board.
- Biosimilars are becoming increasingly established in Europe and show enormous potential in the USA.
Formycon AG, with its head office in Martinsried near Munich, ended the financial year 2013 very successfully and has thus created a comfortable starting position for further positive business development. In December 2013, much earlier than planned, Formycon successfully licensed out the first development project. In addition, Dr. Carsten Brockmeyer, one of the world's leading biosimilar experts, joined the board of directors. In November 2013, Formycon also appointed Dr. Gerhard Schaefer, former Head of Global Product and Business Development at Sandoz International, and Simon Sturge, previously Corporate Senior Vice President at Boehringer Ingelheim, to the advisory board. The company can thus count on further expertise and many years of experience.
Formycon is specialised in the development of biosimilars, the more cost-effective follow-on products of complex, biotechnologically manufactured medicines. Because ever more biotechnologically manufactured medicinal products are being authorised (+ 12-15 % per annum), the market for biosimilars is also increasing: according to estimates, the total volume in the year 2020 will be over 15 billion USD. The large pharmaceutical companies are showing a correspondingly great interest in these products. However, in contrast to the generic preparations of standard, chemically synthesised active substances, the development of biosimilars is very complex and expensive, demanding high requirements from the know-how and experience of the teams.
Concentration on the third wave of biosimilars
Formycon AG is one of the few companies in the world that have the expertise for developing biosimilars – also for highly regulated markets such as Europe, the USA and Japan – and has taken on a clear pioneering role in this innovative and demanding market. "We are concentrating specifically on the so-called third wave of biosimilars, i.e. products whose patents expire as of the year 2020," explains Dr. Nicolas Combé, Director and CFO of Formycon AG.
Partner successfully found for the first project – further licensing out and extension of the pipeline planned
Formycon currently has two projects in development. The company successfully licensed out one of them to Santo Holding GmbH in December 2013, ahead of plan. On behalf of Santo and its partners Andreas and Thomas Strüngmann, founders and former owners of the generics manufacturer HEXAL, Formycon will bring the first development project to market maturity. From this contract, Formycon is reckoning with success-based payments in the mid thousand million range, which will make it possible to realise the further development of the pipeline earlier than planned.
Thanks to this contract and to a very solid investor structure, Formycon is one of the few independent companies operating in this promising market of the biosimilars. "We achieved more than expected in 2013," said Combé. We also reached the milestones for the second development project: after conclusion of the analysis phase, we started with the development of the cell line, so that the second Formycon project is also going according to schedule. The licence options for the second Biosimilar of Formycon’s pipeline are already to be examined in the second half of the year 2014.
On the basis of the unique expertise of the scientists and management as well as the integrated development processes, Formycon is a preferred partner for large pharmaceutical companies in biosimilar development.
Biosimilars are on the advance throughout the world.
Twenty biosimilars have been granted marketing authorisation in the EU to date. Also in other parts of the world (e.g. Switzerland, Turkey, Malaysia, Australia, Japan, Mexico, Taiwan, Korea) several biosimilars are already on the market. In the US, new guidelines for the marketing authorisation of biosimilars are currently being formulated (FDA Draft Guidances on Biosimilars). This will further open up this large market for high-quality biosimilars, as developed by Formycon.
The term "Biosimilar" (Similar Biological Medicinal Product) stands for follow-on preparations of (usually) patented biotechnological medicinal products. The manufacturing process of biopharmaceuticals is not openly accessible, the development of biosimilars requires a high degree of know-how and experience. The manufacturing process takes place in living cells, therefore the biosimilar is never identical to the original preparation, but is similar. The proportion of biotechnologically manufactured medicinal products is constantly increasing. Growth of 12-15 % per annum is currently projected. Consequently, the potential for biosimilars is also growing. According to estimates, biotechnologically manufactured medicinal products with an annual worldwide market volume of over 100 billion USD are due to lose their patent protection by the year 2020. As a result of the complex development process, biosimilars are subject to a less strong price erosion than standard generics: while the decline in the price of generics amounts to around 90 percent, biosimilars are offered around 10-30 percent cheaper than the corresponding original preparations. However, because they may cost between USD 50,000 and USD 130,000 per patient and year, biosimilars create an enormous potential for savings in healthcare costs.
Formycon AG is a leading independent developer of biosimilars for global marketing and has taken on a clear pioneering role in this field. The team at Formycon AG has amassed many years of experience in the development of complex molecules. As early as 2008 and 2011, two protein-based product portfolios were licensed out to large pharmaceutical companies.
As a result of its particular expertise, Formycon AG is in a position to develop high-quality biosimilars that fulfil the strict requirements of the authorities in the highly regulated countries and regions such as Europe and the USA. Formycon currently has two products in development and the first biosimilar candidate has already been licensed out to Santo Holding GmbH. Further project developments are in the planning phase. The aim is to be the first company in the world to present clinical data for the respective product candidates and thus to license the products to large pharmaceutical and generics companies for further development. Alternatively, Formycon offers pursuing market authorisation for the biosimilars on behalf of the licensee and to take on production.